Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma

Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study

This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.

Inclusion Criteria:

• Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
• High Risk of recurrence as assessed by tumor characteristics
• Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
• Child-Pugh Class A statu
• ECOG Performance Status of 0 or 1
• CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
• Expected survival time of no less than 3 months

Exclusion Criteria:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Evidence of residual or a history of spontaneous tumor rupture
• Recurrent HCC
• Prior received Liver transplantation
• Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
• AFP does not return to normal 4 weeks after operation